The phase I/II study indicated that Baxter’s H5N1 candidate vaccine is highly immunogenic at low doses, and induces substantial levels of cross immunity against widely divergent H5N1 strains.
The phase III trial is designed to evaluate the safety and efficacy of Baxter’s adjuvant-free, whole-virus candidate vaccine. Vaccinations will begin in the first half of this year and results of the phase III trial are scheduled to be available by the end of 2007. Recipients will be evaluated for the vaccine’s ability to elicit the production of antibodies to the H5N1 strain A/Vietnam/1203/2004, which is the strain used for the vaccine, and also against a number of other divergent H5N1 strains.
Baxter’s candidate H5N1 vaccine is manufactured using the company’s proprietary vero cell technology, which produces high-yield vaccine more quickly than traditional approaches because it is not produced in eggs. Baxter’s candidate vaccine is the first cell-based candidate H5N1 pandemic vaccine to undergo clinical evaluation.